NCT03422198

Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer

Study Contact:

Rachel Kingsford - Role: CONTACT - Phone: 801-585-0115 - Email: Rachel.Kingsford@hci.utah.edu

Study Phase:

PHASE3

Recruitment Status:

RECRUITING

NCT ID:

NCT03422198

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)

Summary

This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells.

After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.

Eligibility

Inclusion Criteria:

* Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear cell, to include tumors originating in the cervix, but are primarily located in the uterus, and for whom vaginal cuff brachytherapy is indicated. Carcinosarcoma and other sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) stage I, with one of the following combinations of stage and grade:

* Stage IA, grade 2, 3
* Stage IB, grades 1-3
* Stage II, grades 1-3
* Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
* Participants post hysterectomy and free from residual disease.
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance status 0-2.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
* Life expectancy of \>2 years.

Exclusion Criteria:

* Stages of endometrial carcinoma other than described.
* Previous pelvic radiotherapy.
* Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks.

Disease(s) and\or Condition(s)

Endometrial Clear Cell Adenocarcinoma

Endometrial Endometrioid Adenocarcinoma

Endometrial Serous Adenocarcinoma

Stage I Uterine Corpus Cancer

Stage IA Uterine Corpus Cancer

Stage IB Uterine Corpus Cancer

Stage II Uterine Corpus Cancer

Uterine Corpus Carcinosarcoma

Uterine Corpus Sarcoma

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: RADIATION
- Name: Vaginal Cuff Brachytherapy
- Description: Undergo standard of care vaginal cuff brachytherapy
- Arm Group Labels: Vaginal cuff brachytherapy
- Type: RADIATION
- Name: Short course vaginal cuff brachytherapy
- Description: Undergo short course vaginal cuff brachytherapy
- Arm Group Labels: Short course vaginal cuff brachytherapy

Sponsor

University of Utah